CREON 10.000

Israel - English - Ministry of Health

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Active ingredient:
PANCREATIN
Available from:
ABBOTT MEDICAL LABORATORIES LTD, ISRAEL
ATC code:
A09AA02
Pharmaceutical form:
CAPSULES
Composition:
PANCREATIN 150 MG
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
ABBOTT LABORATORIES GMBH , GERMANY
Therapeutic group:
MULTIENZYMES (LIPASE, PROTEASE ETC.)
Therapeutic area:
MULTIENZYMES (LIPASE, PROTEASE ETC.)
Therapeutic indications:
Pancreatic exocrine insufficiency.
Authorization number:
103 48 28837 00
Authorization date:
2011-12-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

26-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed without a doctor’s prescription

CREON 10,000

Capsules

Each capsule contains: Pancreatin 150 mg, comprising:

Lipase 10,000 Ph. Eur. Units

Amylase 8,000 Ph. Eur. Units

Protease 600 Ph. Eur. Units

For the inactive ingredients in the medicine, see section 6.

Read this leaflet carefully in its entirety before using the

medicine. This leaflet contains concise information about the

medicine. If you have further questions, refer to the doctor or

pharmacist. Use this medicine in the correct manner.

Consult a pharmacist if you need further information.

- Creon 10,000 is a pancreatic enzyme supplement indicated

for people whose bodies cannot produce enough enzymes

required to digest food.

- The capsules contain a mix of natural enzymes used to

digest food.

- The enzymes are extracted from pig pancreas.

- The capsules must be taken as per the doctor’s

instructions.

- Take the medicine together with a meal or snack, with a lot

of water (see section 3).

- Do not take the medicine if you are allergic to pig-derived

ingredients, pig proteins (see section 2).

- If you experience severe abdominal pains during the

course of treatment with the medicine, refer to the doctor

immediately (see section 4).

1. WHAT IS THE MEDICINE INTENDED fOR?

The medicine is intended to treat exocrine pancreatic

insufficiency. The medicine contains pancreatic enzymes

which aid digestion, in cases where the pancreas does not

produce these enzymes, or does not produce enough of them.

The medicine is intended to balance low enzymatic activity in

the intestine, in cases of pancreatic insufficiency, e.g., cystic

fibrosis, chronic pancreatitis and malabsorption of lipids also

related to the pancreas.

Therapeutic group: Digestive enzymes.

2. BEfORE USING THE MEDICINE

Do not use the medicine if:

you are sensitive (allergic) to the active ingredient,

pancreatin, to products of pig origin, pig proteins or to any

of the additional ingredients contained in the medicine (see

section 6).

If this section applies to you, do not take the medicine. Consult

with the doctor again.

Special warnings regarding use of this medicine

Before using the medicine, inform the doctor if you are

sensitive to any food or medicine.

Additional warnings

A rare bowel condition called fibrosing colonopathy (narrowing

of the large intestine) has been reported in patients with cystic

fibrosis taking high dosages of preparations containing

pancreatin.

If you have cystic fibrosis and take doses higher than 10,000

lipase units per kilogram body weight per day, refer to a

doctor if you have unusual abdominal symptoms or changes

in regular abdominal symptoms.

If you are taking, or have recently taken, other medicines,

including non-prescription medicines and nutritional

supplements, tell the doctor or pharmacist.

Use of the medicine and food

The digestive enzymes in the medicine act when food is

passing through the intestine, and therefore, the medicine

should be taken with a meal or snack. This will allow the

enzymes to effectively mix with the food (see section 3).

Pregnancy and breastfeeding

If you are pregnant or trying to become pregnant, consult the

doctor or pharmacist before using the medicine.

This medicine can be used when breastfeeding.

Driving and use of machinery

It is unlikely that the medicine will affect your ability to drive

or operate dangerous machinery.

Important information regarding some of the ingredients

in the medicine

The amount of sodium in each capsule: 1.8 mg.

This medicine does not contain sugar or lactose.

3. HOW SHOULD yOU USE THE MEDICINE?

Always use according to the doctor’s instructions.

Check with the doctor or pharmacist if you are uncertain.

The dosage and treatment regimen will be determined by

the doctor only.

If the doctor has told you to increase the dose (to increase

the number of capsules), do so gradually. If you still have fatty

stools or abdominal pains, inform the doctor.

Do not exceed the recommended dose.

Take the medicine during or immediately after a meal or a

snack.

Swallow the medicine with a lot of water.

Do not chew or crush the medicine, so as not to destroy the

inner coating, within which the enzymes are enclosed, thereby

abolishing the enzymatic activity of the medicine.

How should the medicine be taken

Swallow the capsule whole, or, if you have a hard time

swallowing whole capsules, the capsule can be carefully

opened and its contents can be mixed (without mashing) with

an acidic liquid (e.g., apple, orange or pineapple juice) or with

a soft acidic food (e.g., apple sauce or yogurt). If the contents

of the capsule are mixed with food or a beverage, take the

mixture immediately, without mashing or chewing, so that the

inner coating will not dissolve. Do not store the mixture.

Note:

Be sure to maintain adequate fluid intake at all times during

the course of treatment with the medicine, especially when

there is increased fluid loss (e.g., vomiting and diarrhea).

failure to drink adequately may worsen constipation. It

is important to drink a lot every day!

Mashing/chewing the granules in the capsule or mixing the

contents of the capsule with food or a nonacidic beverage

may cause irritation in the mouth or change the way Creon

works in the body.

Do not hold the whole capsule or mixture in the mouth for

more than the time necessary to swallow it.

∙ The bottle is closed with a child-proof cap. Press down and

turn to open it.

Child-proof caps have significantly lowered the number of

poisoning incidents caused by medicines each year. However,

if you are having a hard time opening the package, you can

refer to a pharmacist to have the safety mechanism removed

from the cap and to turn it into a regular, easy-to open-cap.

∙ The capsule can be opened and its contents dispersed.

∙ Do not crush, mash or chew the medicine.

∙ Duration of treatment - continue taking the medicine until

your doctor tells you to stop. Many patients need to take

pancreatic enzyme supplements throughout their lifetime.

If you accidentally took a higher dosage, drink lots of water.

If you took an overdose, or if a child accidentally swallowed

the medicine, immediately refer to a doctor or proceed to

a hospital emergency room, and bring the package of the

medicine with you.

If you forgot to take this medicine at the required time, do not

take a double dose to compensate for the forgotten dose. Take

the next dose with the next meal.

Adhere to the treatment regimen recommended by the

doctor.

Even if there is an improvement in your health, do not stop

treatment with the medicine, without consulting with the

doctor or pharmacist.

Do not take medicines in the dark! Check the label and the

dose each time you take medicine. Wear glasses if you need

them.

If you have further questions regarding use of the medicine,

consult the doctor or pharmacist.

4. SIDE EffECTS

As with any medicine, use of Creon 10,000 may cause side

effects in some users. Do not be alarmed when reading the list

of side effects. You may not suffer from any of them.

If you have severe and long-lasting abdominal pains or

abnormal abdominal symptoms, consult with the doctor

immediately.

The following side effects were reported in clinical trials

conducted among more than 900 patients who took Creon:

Side effects occurring very frequently (affect more than 1

in 10 users):

- stomach pains

Side effects occurring frequently (affect 1-10 in 100 users):

- diarrhea

- constipation

- nausea or vomiting

- bloating

Side effects occurring infrequently (affect 1-10 in 1,000

users):

- Skin reactions, such as a rash.

During use, some patients have also experienced the following

effects, the frequency of which is unknown:

- itching with or without a rash

- allergic reactions (which may be severe, such as breathing

difficulties or swelling of the lips)

- severe or long-lasting abdominal pains (fibrosing

colonopathy)

Severe or long-lasting abdominal pains caused by narrowing of

the large intestine (fibrosing colonopathy) have been reported

in cystic fibrosis patients taking preparations containing high

dosages of pancreatin.

Very high dosages of pancreatin have sometimes caused high

levels of uric acid in the blood and urine.

These effects usually pass within a short time of adaptation to

the medicine. If they persist and/or worsen, refer to a doctor.

Side effects can be reported to the Ministry of Health via

the online form in the following link:

http://forms.gov.il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic%40moh.health.gov.il

If a side effect occurs, if any of the side effects worsen or

if you suffer from a side effect not mentioned in this leaflet,

consult with the doctor.

5. HOW SHOULD THE MEDICINE BE STORED?

∙ Avoid poisoning! This medicine, and any other medicine,

should be kept in a safe place out of the sight and reach of

children and/or infants in order to avoid poisoning. Do not

induce vomiting unless explicitly instructed to do so by the

doctor.

∙ Do not use the medicine after the expiry date (exp. date)

that appears on the package. The expiry date refers to the

last day of that month.

∙ Do not store at a temperature that exceeds 25°C. Close

tightly to prevent penetration of air and moisture. Store in

the original package.

Can be used for 3 months from the time the bottle is first

opened.

∙ The enzymes in the medicine are natural enzymes, whose

capacity to digest food declines with time. If the medicine

is stored in hot temperatures (e.g., the glove box in the car),

the digestive capacities of the enzymes in the medicine will

decline faster.

6. fURTHER INfORMATION

∙ In addition to the active ingredient, the medicine also

contains -

Hypromellose phthalate, Macrogol 4,000, Triethyl citrate,

Dimeticone 1,000, Cetyl alcohol.

Capsule: Gelatine, Iron oxides (red, yellow, black) (E172),

Sodium lauryl sulphate, Titanium dioxide (E171).

Each capsule contains 1.8 mg sodium

∙ What the medicine looks like and the contents of the

package - the medicine is composed of brownish granules

in hard gelatin capsules.

The medicine is sold in a carton box that contains a bottle

with a child-safety cap.

Package sizes - 100 capsules, 200 capsules.

Not all package sizes are marketed.

∙ Registration holder and address: Abbott Medical

Laboratories Ltd., Kiryat Atidim, P.O.B. 58099, Tel-Aviv.

∙ Manufacturer: Abbott Laboratories GmbH, Hanover,

Germany.

∙ This leaflet was checked and approved by the Ministry of

Health in June 2015.

∙ Registration number of the medicine in the National Drug

Registry of the Ministry of Health: 103-48-28837-00

Summary of Product Characteristics

CREON

10,000

1.

NAME OF THE MEDICINAL PRODUCT

Creon 10,000

capsules

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One capsule Creon 10,000 contains:

150 mg pancreatin (pancreas powder) corresponding to

Amylase

8,000 Ph.Eur. units

Lipase

10,000 Ph.Eur. units

Protease

600 Ph.Eur. units

For a full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

gastro-resistant capsule, hard (hard gelatin capsules filled with gastro-resistant pellets (=Minimicro

spheres™).

Bicoloured capsule with brown opaque cap and transparent body.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the treatment of Pancreatic exocrine insufficiency.

Enzyme replacement therapy in patients with deficient exocrine pancreatic secretions, cystic fibrosis,

chronic

pancreatitis,

postpancreatectomy,

ductal

obstructions

caused

cancer

pancreas,

pancreatic insufficiency and for steatorrhea of malabsorption syndrome and postgastrectomy (Billroth II

and Total).

Presumptive

test

pancreatic

function,

especially

pancreatic

insufficiency

chronic

pancreatitis.

4.2

Posology and method of administration

The posology aims at individual needs and depends on the severity of the disease and the composition of

food.

It is recommended to take the enzymes during or immediately after each meal or snack.

Adults (including the elderly) and children:

Initially one to two capsules with each meal.

Doses increases, if required, should be added slowly, with careful monitoring of response and

symptomatology.

The capsules can be swallowed whole, or for ease of administration they may be opened and the

granules taken with acidic fluid or soft food, but without chewing.

This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or

pineapple juice. If the granules are mixed with fluid or food it is important that they are taken

immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order

to protect the enteric coating, it is important that the granules are not crushed or chewed

Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5

can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity

and may lead to reduced efficacy and irritation of the mucous membranes.

Care should be taken that no product is retained in the mouth.

It is important to ensure adequate hydration at all times, whilst dosing Creon especially during periods

of increased loss of fluids. Inadequate hydration may aggravate constipation. Any mixture of the

minimicrospheres with food or liquids should be used immediately and should not be stored.

Dosing in paediatric and adult patients with cystic fibrosis

Based upon a recommendation of the Cystic Fibrosis Consensus Conference, the US CF Foundation

case-control study, and the UK case-control study, the following general dosage recommendation for

pancreatic enzyme replacement therapy can be proposed:

Weight-based enzyme dosing should begin with 1000 lipase units/kg/meal for children

less than four years of age and with 500 lipase units/kg/meal for those over age four.

Dosage

should

adjusted

according

severity

disease,

control

steatorrhea and maintenance of good nutritional status.

Most patients should remain below or should not exceed 10000 U/kg body weight per

day or 4000 lipase units/gram fat intake.

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units

of lipase/kg/day (see section 4.4).

Dosing in other conditions associated with exocrine pancreatic insufficiency

Dosage should be individualized by patient according to the degree of maldigestion and the fat content

of the meal. The required dose for a main meal (breakfast, lunch or dinner) ranges from about 25000 to

80000 Ph. Eur. U of lipase and half of the individual dose for snacks.

4.3

Contraindications

Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

4.4

Special Warnings and precautions for use The product is of porcine origin

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients

with cystic fibrosis taking high doses of pancreatin preparations. As a precaution,

unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to

exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000

units of lipase/kg/day.

4.5

Drug interactions

No interaction studies have been performed.

4.6

Pregnancy and lactation

Pregnancy:

For pancreatic enzymes no clinical data on exposed pregnancies are available. Animal studies show no

evidence of absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental

toxicity is to be expected. Caution should be exercised when prescribing to pregnant women.

Lactation:

No effects on the suckling child are anticipated, since animal studies suggest no systemic exposure of

the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breastfeeding.

If required during pregnancy and lactation Creon should be used in doses sufficient to provide adequate

nutritional status.

4.7

Effects on ability to drive and use machines

Creon has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects

In clinical trials, more than 900 patients were exposed to Creon. The most commonly reported adverse

reactions were gastrointestinal disorders and were primarily mild or moderate in severity.

The following adverse reactions have been observed during clinical trials with the below indicated

frequencies

*Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower

incidences compared to placebo were reported for abdominal pain and diarrhea.

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in

patients with cystic fibrosis taking high doses of pancreatin preparations, see section 4.4 Special

warnings and precautions for use.

Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as

adverse reactions during post-approval use. Because these reactions were reported spontaneously

form a population of uncertain size, it is not possible to reliably estimate their frequency.

Organ system

Very common

>1/10

Common >1/100

to <1/10

Uncommon

>1/1000 to <1/100

Frequency not

known

Gastrointestinal

disorders

abdominal

pain*

nausea,

vomiting,

constipation,

abdominal

distention,

diarrhea*

strictures of the

ileo-caecum and

large bowel

(fibrosing

colonopathy)

Skin and

subcutaneous

tissue disorders

rash

pruritus,

urticaria

Immune system

disorders

hypersensitivity

(anaphylactic

reactions).

Paediatric population

No specific adverse reactions were identified in the pediatric population. Frequency, type and severity

of adverse reactions were similar in children with cystic fibrosis as compared to adults.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.heal

th.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL)

4.9

Overdose

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and

hyperuricaemia.

Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are

recommended.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties

Pharmacotherapeutic group: Multienzymes (amylase, lipase, protease), ATC code: A09A A02

Creon

10000

contains

porcine

pancreatin

formulated

enteric-coated

(acid-resistant)

minimicrospheres within gelatine capsules. The capsules dissolve rapidly in the stomach releasing

plenty of minimicrospheres, a multi-dose principle which is designed to achieve good mixing with the

chyme, emptying from the stomach together with the chyme and after release, good distribution of

enzymes within the chyme.

When the minimicrospheres reach the small intestine the coating rapidly disintegrates (at pH>5.5) to

release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats,

starches and proteins. The products of pancreatic digestion are then either absorbed directly, or

following further hydrolysis by intestinal enzymes.

Clinical efficacy:

Overall 30 studies investigating the efficacy of Creon (Creon capsules with 10000,

25000 or 40000 Ph. Eur units of lipase and Creon 5000) in patients with pancreatic exocrine

insufficiency have been conducted. Ten of these were placebo controlled studies performed in

patients with cystic fibrosis, chronic pancreatitis or post-surgical conditions.

In all randomized, placebo-controlled, efficacy studies, the pre-defined primary objective was to show

superiority of Creon over placebo on the primary efficacy parameter, the coefficient of fat absorption

(CFA).

The coefficient of fat absorption determines the percentage of fat that is absorbed into the body taking

into account fat intake and fecal fat excretion. In the placebo-controlled PEI studies, the mean CFA (%,

mean ± SD) was higher with Creon treatment (83.0%± 12.6%) as compared to placebo (62.6%± 21.8%).

The median treatment duration was 7 days on both treatments.

In all studies, irrespective of the design, the mean CFA (%) at the end of the treatment period with

Creon was similar to the mean CFA values for Creon in the placebo- controlled studies.

In all performed studies, irrespective of etiology, an improvement was also shown in disease specific

symptomatology (stool frequency, stool consistency, flatulence).

Paediatric population:

In cystic fibrosis (CF) the efficacy of Creon was demonstrated in 288 paediatric patients covering an age

range from newborns to adolescents. In all studies, the mean end-of-treatment CFA values exceeded

80% on Creon comparably in all pediatric age groups.

5.2

Pharmacokinetic Properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After

exerting their action, the enzymes are digested themselves in the intestine.

5.3

Preclinical Safety Data

None stated.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Granules core: Macrogol 4000

Granules coating:

Hypromellose phthalate, cetyl alcohol, triethyl citrate, dimethicone 1000

Capsule shell:

Gelatine, iron oxides (red, yellow, black) (E172), titanium dioxide (E171), sodium

lauryl sulphate

6.2

Incompatibilities

Not applicable

6.3

Shelf life

2 years. Shelf life after first opening: 3 months or expiry date which ever comes first

6.4

Special precautions for storage

Do not store above 25°C, keep the container tightly closed in order to protect from moisture.

6.5

Nature and content of container

HDPE container with tamper-evident child resistant PP cap. Containers hold 100 or 200

capsules.

7

. MANUFACTURER:

Abbott Laboratories GmbH, Hannover, Germany.

8.

REGISTRATION HOLDER:

Abbott Medical Laboratories Ltd., Kiryat Atidim, POB 58099,

Tel – Aviv

9

.

REGISTRATION NUMBER: 103-48-28837-00

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ןכרצל

ןכדועמ(

05.2013

ךיראת

29.12.2014

םש

רישכת

תילגנאב

רפסמו

םושירה

Creon 10000: 103-48-28837-00

םש

לעב

םושירה

טובא

תודבעמ

תויאופר

מ"עב

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה

קרפ

ןולעב טסקט

יחכונ טסקט

שדח

ןיא יתמ שמתשהל

?

רישכתב שמתשהל ןיא ךל העודי םא תושיגר וא הפורתה יביכרממ דחאל ינובלחל ריזח

רמוחל )יגרלא( שיגר התא ,ןיטארקנפ ,ליעפה ריזח לש יח רוקממ םיביכרל

ריזח ינובלחל , וא דחא לכל

הליכמ רשא םיפסונה םיביכרמהמ הפורתה

ףיעס האר

תא לוטיל ןיא ,ךיילע לח הז ףיעסו הדימב .הפורתה

.אפורה םע בוש ץעוויהל שי

תורהזא ןוארק

10,000

ןיטארקנפ ליכמ ריזח לש בלבל תמקרמ קפומה ומכ ,לכאמ יכרצל לדוגמה םירחא םיקוושמ םירישכתב .ריזח רוקממ ןיטארקנפ םיליכמה םרוג תרבעהל ןוכיסהש תורמל ןוארק תועצמאב םדא ינבל םהזמ

10,000

תוקידב י"ע תחפומ םיסוריו לש היצביטקאניאו רוציי ןמזב תועצבתמה ,םימייוסמ יטרואית ןוכיס םייק ,רישכתה ללוכ ,תילאריו הלחמ תרבעהל םיסוריו י"ע תומרגנה תולחמ ןתינ אל .םיהוזמ אל וא םישדח םיסוריו תואצמיה ןיטולחל לולשל .םדא ינב קיבדהל םילולעה ,הלא םירקמ לע חווד אל ,תאז םע דחי תמהזמ הלחמ תרבעה לש בלבל ימיזנאב שומישב הרושקה ריזח רוקממ קחמנ טסקט

ןוזמבו הפורתב שומיש ןוזמה רשאכ םילעופ הפורתבש לוכיעה ימיזנא םע דחי הפורתה תא לוטיל שי ןכלו ,יעמב רבוע רשפאי הז בצמ .ףיטח תליכא וא החורא ןוזמה םע תוליעיב בברעתהל םימיזנאל

האר( ףיעס

תונוכמב שומישו הגיהנ ךלש תלוכיה לע עיפשת הפורתהש ריבס אל .תונכוסמ תונוכמ ליעפהל וא גוהנל

:

הקנהו ןוירה ץעוויהל ילבמ הפורתב שמתשהל ןיא :לופיטה תלחתה ינפל אפורב ןתינ( הקינמ וא ןוירהב ךניה םא םא ךניה ןוירהב ןוירהל סנכיהל הסנמ וא

שי וא אפורב ץעוויהל

חקור שומישה ינפל הפורתב

.)הקנהה תפוקתב הפורתב שמתשהל הקנהב הפורתב שמתשהל ןתינ

שמתשת דציכ

:

הפורתב .אפורה תוארוה יפל ןונימ .תצלמומה הנמה לע רובעל ןיא ךלהמב הפורתה תא לוטיל שי רחאל דימ וא ףיטח תליכא וא החוראה .ףיטח תליכא וא החוראה י/גלד ,ןמזב הנמ לוטיל תחכש םא החוראה דע הנמ י/חקית לאו הילע .האבה

.........

:שומישה ןפוא םע ןתומלשב תוסומכה תא עולבל שי טעמ .םימ ,הפורתה תא ךועמל וא סועלל ןיא ימינפה יופיצה תא סורהל אל ידכ תא לטבל ךכבו םימיזנאה םיפוטע וב .הפורתה לש תיטמיזנאה תוליעפה

........

.אפורה תוארוה יפל שמתשהל שי דימת ךניא םא חקורה וא אפורה םע קודבל ךילע .חוטב .דבלב אפורה ידי לע ועבקי לופיטה ןפואו ןונימה תולעהל( הנמה תא לידגהל ךל ץעיי אפורה םא תאז תושעל ךילע ,)תוסומכה רפסמ תא יבאכ וא תינמוש האוצ ןיידע ךל שי םא .הגרדהב אפורל ךכ לע רפסל ךילע ,ןטב

תצלמומה הנמה לע רובעל ןיא החוראה רחאל דימ וא ךלהמב הפורתה תא לוטיל שי .ףיטח תליכא וא םע הפורתה תא עולבל שי הברה

.םימ סורהל אל ידכ ,הפורתה תא ךועמל וא סועלל ןיא ךכבו םימיזנאה םיפוטע וב ימינפה יופיצה תא .הפורתה לש תיטמיזנאה תוליעפה תא לטבל

...........

-לופיטה ךשמ דע הפורתה תליטנב ךישמהל שי םילפוטמ .קיספהל אפורהמ היחנה לבקתש בלבל ימיזנא לש םיפסות לוטיל םיכירצ םיבר םהייח לכ ךשמב

,רתוי הובג ןונימ תועטב תלטנ םא תותשל שי םימ לש תולודג תויומכ

וא רתי תנמ תלטנ םא . םא

תועטב

עלב

דלי

הנפ ,הפורתה ןמ

דימ אפורל

וא

רדחל

ןוימ

לש

תיב

םילוח

אבהו

תא תזירא

הפורתה

.ךתיא

תא ןסחאל ךיא

?

הפורתה -ל תחתמ

25°C

י/ענמו בטיה י/רוגס . .תוביטרו ריווא תרידח הנסחאה/הזיראה יאנת יפל םג תורמשנ תופורת ,םיצלמומה ןיא .דבלב תלבגומ הפוקתל ךיראת ירחא הפורתב שמתשהל ( הגופתה

exp. date

לע עיפומה םויל סחייתמה, הזיראה יבג רחאל וא שדוח ותוא לש ןורחאה

החיתפה דעוממ םישדוח .םהינבמ םדקומה,הנושארה לע הלועה הרוטרפמטב ןסחאל ןיא

שי .

בטיה רוגס עונמלו ןסחא .תוביטרו ריווא תרידח .תירוקמה הזיראב ןתינ

שמתשהל

ךשמב

םישדוח

רחאל

דעומ החיתפה

הנושארה

לש

קובקבה

בש םימיזנאה הפורת םייעבט םימיזנא םה םא .ןמז ךרואל הנטק ןוזמ לכעל םתלוכיש את :ןוגכ( המח הרוטרפמטב תנסחואמ הפורתה לש לוכיעה תוליעפ תלוכי ,)בכרה לש תופפכ םימיזנאה הפורתב .רתוי רהמ ןטקת

"

ב צמ

נמוסמ ובש ןולעה תו

תורמחהה שקובמה

תו

בוהצ עקר לע

טסקטב ןולעב ונמוס תורמחה רדגב םניאש םייוניש

לוחכ

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ל

אפור ןכדועמ(

05.2013

)

ךיראת

29.12.2014

םש

רישכת

תילגנאב

רפסמו

םושירה

Creon 10000: 103-48-28837-00

םש

לעב

םושירה

טובא

תודבעמ

תויאופר

מ"עב

! דבלב תורמחהה טורפל דעוימ הז ספוט תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Posology and

method of

administration

Fibrosing colonopathy has been reported

in patients with cystic fibrosis taking in

excess of 10,000 units of lipase/kg/day

(see section 4.4).

Special Warnings

and Special

Precautions for

Use

As with all currently marketed

porcine pancreatin products, Creon is

sourced from pancreatic tissue from

swine used for food consumption.

Although the risk that Creon will

transmit an infectious agent to

humans has been reduced by the

testing and inactivation of certain

viruses during manufacturing, there

is a theoretical risk for transmission

of viral disease, including diseases

caused by novel or unidentified

viruses. The presence of porcine

viruses that might infect humans

cannot be definitely excluded.

However, no cases of transmission of

an infectious illness associated with

the use of porcine pancreatic extracts

have been reported, whereas they

have been used for a long time.

Text deleted

Overdose

Extremely high doses of

pancreatin have been reported to

be associated with hyperuricosuria

and hyperuricaemia.

Extremely high doses of pancreatin have

been reported to be associated with

hyperuricosuria and hyperuricaemia.

Supportive measures including stopping

enzyme therapy and ensuring adequate

rehydration are recommended.

"

ב צמ

נמוסמ ובש ןולעה תו

תורמחהה שקובמה

תו

בוהצ עקר לע

טסקטב ןולעב ונמוס תורמחה רדגב םניאש םייוניש

לוחכ

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